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ICCVAM Participation on EURL ECVAM Activities

The International Cooperation on Alternative Test Methods (ICATM) facilitates cooperation, collaboration, and communication among national organizations that validation and promote the use of alternative approaches for chemical safety testing. As an example, ICCVAM has developed the following approach for participating in activities of the European Union Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM).

Download graphic: ICCVAM Participation on EURL ECVAM Activities

  1. EURL ECVAM assesses a submission of an alternative test method for evaluation, its scientific and regulatory aspects, and its stakeholder relevance
    • EURL ECVAM and ICCVAM liaisons collaborate to prepare ICCVAM briefing, to present at next ICCVAM teleconference with any relevant materials
  2. EURL ECVAM develops Validation Project Plan, performs validation study (if needed), and prepares Validation Study Report
    • ICCVAM determines level of interest, identifies stakeholder agencies, and nominates Validation Management Team liaisons
    • ICCVAM Validation Management Team liaisons provide feedback on draft Validation Project Plan
    • ICCVAM Validation Management Team liaisons monitor progress of study and update ICCVAM and relevant ICCVAM working group
    • ICCVAM Validation Management Team liaisons provide feedback on draft Validation Study Report
  3. EURL ECVAM convenes Scientific Advisory Committee (ESAC) review of the validation study conduct and Validation Study Report conclusions
    • ICCVAM nominates experts for ESAC working group
    • ICCVAM reviews and provides feedback on ESAC Report and Opinion
  4. EURL ECVAM develops draft EURL ECVAM recommendations, negotiating with ICATM partners to develop harmonized recommendations
    • ICCVAM assesses relevance of EURL ECVAM draft recommendations to U.S. regulatory agencies
    • ICCVAM identifies additional activities needed for U.S. adoption
    • ICCVAM identifies and plans response to EURL ECVAM recommendation
  5. EURL ECVAM receives public input on draft recommendation; EURL ECVAM issues final recommendation, ESAC Report and Opinion, and Validation Study Report
    • ICCVAM publicizes EURL ECVAM recommendation on website and email list
    • ICCVAM assesses relevance of recommendation to U.S. regulation
    • ICCVAM announces any further ICCVAM activities, which may include:
      • Additional validation: testing of additional substances to expand domain or compare to other methods; additional analysis (e.g. using U.S. categorization); testing at additional laboratories to assess transferability
      • Workshops or collection of additional data via requests published in the Federal Register
      • Only when required, issue a formal ICCVAM recommendation and transmittal to agencies; this may require a new peer review if additional data or analysis is used to develop the formal ICCVAM recommendation